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CompletedNCT03660943Updated Jul 21, 2022Results posted

A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain

A Phase 3 interventional study of Placebo and CNTX-4975-05 in Osteoarthritis, Knee, sponsored by Centrexion Therapeutics. Completed at 30 sites in United States. Open to participants aged 40 Years to 95 Years. Per ClinicalTrials.gov, last updated 2022-07-21.

Sponsored by Centrexion Therapeutics · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
332
Allocation
Randomized
Ages
40 Years to 95 Years
Sex
All
01

Study summary

This is a randomized, double-blind, placebo-controlled, 2-injection, 52-week study to evaluate the efficacy and safety of intra-articular injections of CNTX-4975-05 in subjects with chronic, moderate-to-severe osteoarthritis knee pain.

02

Conditions studied

  • Osteoarthritis, Knee

Keywords

  • Osteoarthritis
  • Knee Pain
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 332 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Centrexion Therapeutics is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Male or female subjects between 40 and 95 years of age (inclusive) at the time of the Screening Visit with the ability to comply with answering the electronic diary using the study- provided tablet computers.
  • Confirmation of osteoarthritis (OA) of the knee.
  • Confirmation of the OA of the index knee.
  • Moderate to severe pain in the index knee associated with OA must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator.
  • Body Mass Index (BMI) ≤45 kg/m\^2
  • Must have failed 2 or more prior therapies.

Exclusion Criteria:

  • Joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 24 months.
  • Prior arthroscopic surgery of the index knee within 6 months of Screening.
  • Any painful conditions of the index knee due to joint disease other than the OA.
  • Periarticular pain from any cause.
  • Other chronic pain anywhere in the body that requires the use of analgesic medications.
  • Instability of the index knee.
  • Misalignment (>10 degrees varus or valgus) of the index knee on standing.
  • Documented history of neuropathic arthropathy or finding of bony fragmentation in the index knee with imaging.
  • Physical/ occupational/ chiropractic therapy for the lower extremities or acupuncture for the lower extremities within 30 days of Screening, or need for such therapy during the study.
  • Plans to have surgery, other invasive procedures, or IA injections while participating in the study.
  • Has used topical capsaicin on the index knee within 90 days of Screening.
  • Current use of opioids for any condition other than for OA of the index knee.
  • Corticosteroid injection into the index knee within 90 days of Screening.
  • Received IA viscosupplementation (eg, Synvisc®, Hyalgan®) within 90 days of Screening.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
332 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Matching placebo of 2.0 mL for IA injection

    Drug: Placebo

  • Experimental
    CNTX-4975-05

    Pre-filled glass syringes administered as a single 2.0 mL IA injection

    Drug: CNTX-4975-05

Interventions

  • DrugPlacebo

    Receiving Placebo Injection

  • DrugCNTX-4975-05

    Receiving CNTX-4975-05 Injection

06

What researchers measure

Primary outcomes

  1. Mean Change From Baseline in WOMAC A (Pain) Dimension

    The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme). The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome. The pain dimension includes 5 items about the amount of pain experienced doing various activities (walking, stair climbing, nocturnal, at rest, weight bearing). The score ranges from 0 to 50.

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee

    Average daily OA pain in the index knee while walking was evaluated using a 0 to 10 Numerical Pain Rating Scale (NPRS) (0 = no pain and 10 = worst possible pain). 0 was the best score and 10 was the worst score. Subjects used an ePRO at bedtime (9:00 PM ± 3 hours) to record on a daily basis their average daily OA knee pain score with walking during the previous 24 hours.

    Time frame: Baseline, Week 12

  2. Mean Change From Study Baseline in WOMAC B (Stiffness) Dimension

    The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme). The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome. The stiffness dimension has 2 items: joint stiffness upon wakening and joint stiffness later in the day. The score ranges from 0 to 20.

    Time frame: Baseline, Week 12

  3. Mean Change From Study Baseline in WOMAC C (Function) Dimension

    The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme). The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome. The function dimension asks about the degree of difficulty in doing 17 activities due to the reference joint. The score ranges from 0 to 170.

    Time frame: Baseline, Week12

07

Results

Posted Jul 21, 2022

Participant flow

Participant flow — Overall Study
MilestonePlaceboCNTX-4975-05 (Trans-capsaicin)
Started145187
Treated140184
Completed109134
Not completed3653
Withdrew: Adverse event53
Withdrew: Death02
Withdrew: Lost to follow-up73
Withdrew: Protocol violation35
Withdrew: Withdrawal by subject815
Withdrew: Lack of efficacy912
Withdrew: Withdrawal for other treatment; unable to complete injection procedures413

Outcome measures

PrimaryMean Change From Baseline in WOMAC A (Pain) Dimension

The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme). The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome. The pain dimension includes 5 items about the amount of pain experienced doing various activities (walking, stair climbing, nocturnal, at rest, weight bearing). The score ranges from 0 to 50.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · score on a scale
Mean Change From Baseline in WOMAC A (Pain) Dimension
score on a scalePlaceboCNTX-4975-05
Mean Change From Baseline in WOMAC A (Pain) Dimension-14.13 ± 12.217-17.16 ± 12.266
Statistical analysis
  • Placebo vs CNTX-4975-05 · Mixed Models Analysis · p = 0.0833 · Mean difference (final values): -2.07 · 95% CI -4.42 to 0.27
SecondaryChange From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee

Average daily OA pain in the index knee while walking was evaluated using a 0 to 10 Numerical Pain Rating Scale (NPRS) (0 = no pain and 10 = worst possible pain). 0 was the best score and 10 was the worst score. Subjects used an ePRO at bedtime (9:00 PM ± 3 hours) to record on a daily basis their average daily OA knee pain score with walking during the previous 24 hours.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · score on a scale
Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee
score on a scalePlaceboCNTX-4975-05
Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee-2.99 ± 0.213-3.41 ± 0.197
Statistical analysis
  • Placebo vs CNTX-4975-05 · Mixed Models Analysis · p = 0.0935 · Mean difference (final values): -0.42 · 95% CI -0.91 to 0.07
SecondaryMean Change From Study Baseline in WOMAC B (Stiffness) Dimension

The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme). The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome. The stiffness dimension has 2 items: joint stiffness upon wakening and joint stiffness later in the day. The score ranges from 0 to 20.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · score on a scale
Mean Change From Study Baseline in WOMAC B (Stiffness) Dimension
score on a scalePlaceboCNTX-4975-05
Mean Change From Study Baseline in WOMAC B (Stiffness) Dimension-5.36 ± 0.434-6.58 ± 0.404
Statistical analysis
  • Placebo vs CNTX-4975-05 · Mixed Models Analysis · p = 0.0163 · Mean difference (final values): -1.22 · 95% CI -2.22 to -0.23
SecondaryMean Change From Study Baseline in WOMAC C (Function) Dimension

The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme). The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome. The function dimension asks about the degree of difficulty in doing 17 activities due to the reference joint. The score ranges from 0 to 170.

Time frame:
Baseline, Week12
Reported as:
Least squares mean · score on a scale
Mean Change From Study Baseline in WOMAC C (Function) Dimension
score on a scalePlaceboCNTX-4975-05
Mean Change From Study Baseline in WOMAC C (Function) Dimension-49.03 ± 3.541-57.02 ± 3.307
Statistical analysis
  • Placebo vs CNTX-4975-05 · Mixed Models Analysis · p = 0.0509 · Mean difference (final values): -7.99 · 95% CI -16.01 to 0.03

Adverse events

Collected over 1 Year. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/140 (0%)9/140 (6.4%)34/140 (24.3%)
CNTX-4975-05 (Trans-capsaicin)2/184 (1.1%)9/184 (4.9%)70/184 (38%)
Most frequent serious events
Showing 10 of 28
Most frequent serious events
EventPlaceboCNTX-4975-05 (Trans-capsaicin)
Respiratory FailureRespiratory, thoracic and mediastinal disorders0/1402/184
EmphysemaRespiratory, thoracic and mediastinal disorders1/1400/184
Angina unstableCardiac disorders1/1400/184
Coronary artery diseaseCardiac disorders1/1400/184
Malignant melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1401/184
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1400/184
DiverticulitisInfections and infestations1/1400/184
Peritoneal abscessInfections and infestations1/1400/184
Cholecystitis acuteHepatobiliary disorders1/1400/184
Cervical vertebral fractureInjury, poisoning and procedural complications1/1400/184
Most frequent other events
Showing 10 of 14
Most frequent other events
EventPlaceboCNTX-4975-05 (Trans-capsaicin)
Viral upper respiratory tract infectionInfections and infestations5/14013/184
ArthralgiaMusculoskeletal and connective tissue disorders1/14010/184
Upper respiratory tract infectionInfections and infestations6/1404/184
Procedural dizzinessInjury, poisoning and procedural complications1/1407/184
BronchitisInfections and infestations2/1406/184
Musculoskeletal painMusculoskeletal and connective tissue disorders4/1400/184
SinusitisInfections and infestations3/1405/184
NauseaGastrointestinal disorders1/1405/184
Urinary tract infectionInfections and infestations3/1404/184
Back PainMusculoskeletal and connective tissue disorders1/1404/184

Baseline characteristics

The safety population is defined as any subject that received any amount of investigational product

Age, Continuous
Age, Continuous(years)PlaceboCNTX-4975-05 (Trans-capsaicin)Total
Mean62.8 ± 8.5962.8 ± 8.8062.8 ± 8.70
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboCNTX-4975-05 (Trans-capsaicin)Total
Female84115199
Male5669125
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboCNTX-4975-05 (Trans-capsaicin)Total
Hispanic or Latino375693
Not Hispanic or Latino103128231
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboCNTX-4975-05 (Trans-capsaicin)Total
American Indian or Alaska Native224
Asian202
Native Hawaiian or Other Pacific Islander000
Black or African American374986
White97131228
More than one race101
Unknown or Not Reported123
Body Mass Index (kg/m^2)
Body Mass Index (kg/m^2)(kg/m^2)PlaceboCNTX-4975-05 (Trans-capsaicin)Total
Mean32.40 ± 5.26532.37 ± 5.89532.38 ± 5.623
Study Baseline WOMAC A (Pain) Domain Score (range 0-50)
Study Baseline WOMAC A (Pain) Domain Score (range 0-50)(score on a scale)PlaceboCNTX-4975-05 (Trans-capsaicin)Total
Mean31.3 ± 7.231.6 ± 7.3631.5 ± 7.28
Study Baseline WOMAC B (Stiffness) Domain Score (range 0-20)
Study Baseline WOMAC B (Stiffness) Domain Score (range 0-20)(score on a scale)PlaceboCNTX-4975-05 (Trans-capsaicin)Total
Mean13.2 ± 3.4113.2 ± 3.1513.2 ± 3.26
Study Baseline WOMAC C (Function) Domain Score (range 0-170)
Study Baseline WOMAC C (Function) Domain Score (range 0-170)(score on a scale)PlaceboCNTX-4975-05 (Trans-capsaicin)Total
Mean107.9 ± 26.71109.5 ± 25.89108.8 ± 26.22

1 further baseline measures are reported on the registry.

08

Study locations

30 sites
  • Holland Center for Family Health
    Glendale, Arizona 85306, United States
  • GB Family Care
    Phoenix, Arizona 85037, United States
  • Arizona Research Center
    Phoenix, Arizona 85053, United States
  • Med Center Medical Clinic
    Carmichael, California 95608, United States
  • TriWest Research Associates
    El Cajon, California 92020, United States
  • Arthritis Care and Research Center, Inc. (ACRC Studies)
    Poway, California 92064, United States
  • Chase Medical Research, LLC
    Waterbury, Connecticut 06708, United States
  • San Marcus Research Clinic, Inc.
    Miami Lakes, Florida 33014, United States
  • Panamerican Health Center, Inc.
    Miami, Florida 33126, United States
  • Well Pharma Medical Research, Corp
    Miami, Florida 33143, United States
  • Quality Research & Medical Center LLC
    Miami, Florida 33186, United States
  • Journey Research, Inc.
    Oldsmar, Florida 34677, United States
  • M&M Clinical Trials Sunrise
    Sunrise, Florida 33351, United States
  • Conquest Research
    Winter Park, Florida 32789, United States
  • Better Health Clinical Research, Inc.
    Newnan, Georgia 30265, United States
  • Healthcare Research Network, LLC
    Flossmoor, Illinois 60422, United States
  • Affinity Clinical Research Institute
    Oak Brook, Illinois 60523, United States
  • DelRicht Research
    New Orleans, Louisiana 70115, United States
  • The Center for Rheumatology and Bone Research
    Wheaton, Maryland 20902, United States
  • BTC of New Bedford, LLC
    New Bedford, Massachusetts 02740, United States
  • Healthcare Research Network
    Hazelwood, Missouri 63042, United States
  • Office of Robert P. Kaplan, DO
    Las Vegas, Nevada 89119, United States
  • Drug Trials America
    Hartsdale, New York 10530, United States
  • Lillestol Research LLC
    Fargo, North Dakota 58104, United States
  • Coastal Carolina Research Center at Arcis Healthcare, LLC dba Lowcountry Orthopaedics & Sports Medicine
    North Charleston, South Carolina 29406, United States
  • Heartland Medical, PC
    New Tazewell, Tennessee 37825, United States
  • First Surgical Hospital
    Bellaire, Texas 77401, United States
  • Clinical Trials of Texas, Inc
    San Antonio, Texas 78229, United States
  • DCT-Stone Oak, LLC dba Discovery Clinical Trials
    San Antonio, Texas 78258, United States
  • Spectrum Medical, Inc.
    Danville, Virginia 24541, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 12, 2020

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03660943
Lead sponsor
Centrexion Therapeutics
Responsible party
Sponsor
First posted
Sep 7, 2018
Start date
Sep 9, 2018
Primary completion
Jun 11, 2020
Completion
Jun 11, 2020
Results posted
Jul 21, 2022
Last update
Jul 21, 2022

Study contacts

Randall Stevens, MD
study chair · Centrexion Therapeutics

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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